← Back to catalogue
Atrium Oasis Dry Suction Water Seal, Infant/ Pediatric Chest Drains
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3612-100Model 3600-100
Identity
- Trade Name
- Atrium Oasis Dry Suction Water Seal, Infant/ Pediatric Chest Drains EUDAMEDOASIS FDA UDI
- Generic Name
- Thoracic suction collection container FDA UDI
- Device Name
- Atrium Oasis Dry Suction Water Seal Chest Drain EUDAMEDOASIS DRAIN, PEDIATRIC INLINE & CLAMP FDA UDI
- Model / Reference
- 3600-100 EUDAMED3612-100 EUDAMEDFDA UDI
- Description
- OASIS DRAIN, PEDIATRIC INLINE & CLAMP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650862111019 EUDAMEDFDA UDI
- Basic UDI-DI
- 0650862RA000019ZL EUDAMED
- 510(k) Number
- K043140 FDA UDI
- FDA Product Code
- KDQ FDA UDI
- EMDN Code
- A0699 DRAINAGE AND FLUID COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Thoracic suction collection container FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Atrium Oasis Dry Suction Water Seal, Infant/ Pediatric Chest Drains by Atrium Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0650862RA000019ZL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atrium Medical Corporation
- EUDAMED SRN
- US-MF-000003282
- Authorised Representative
- MAQUET Critical Care AB SE-AR-000001442
Sources (2)
- EUDAMED 3c613226-d830-4dc3-b468-6a24f3dae3c0 61 fields · synced Jul 14, 2026
- FDA UDI c9437d7a-3acc-4943-8079-09945882f30f 35 fields · synced May 30, 2026